AccessGUDID - DEVICE: Progreat Lambda (04987350741004)

GUDID

Device Identifier (DI) Information

Brand Name: Progreat Lambda
Version or Model: CC*M1916AN
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CCM1916AN
Company Name: TERUMO CLINICAL SUPPLY CO., LTD.

Primary DI Number: 04987350741004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 691034748 *Terms of Use

Device Description: Micro Catheter System

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
10691	Vascular microcatheter	A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQO	Catheter, Intravascular, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211078	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Fragile. Keep dry. Keep away from sunlight.

Clinically Relevant Size

[?]

Size Type Text
Length: 165 Centimeter
Catheter Inner Diameter: 0.48 Millimeter
Outer Diameter: 0.64 Millimeter

Device Record Status

Public Device Record Key: d118481f-089a-4856-a368-22943033af8f
Public Version Date: April 15, 2022
Public Version Number: 1
DI Record Publish Date: April 07, 2022